TUV Audits - 21 CFR 820

[Achal]

Hello Folks,

I wanted your quick insights on TUV audits. I am a beginner at a Manufacturing Company.
Could you please share your views- What TUV looks into specifically during auditing pertaining 21 CFR 820?

Any advice or experience will be really helpful.

Thank You,
Achal

 

[indubioush]

My first reaction was, "TUV doesn't audit against 21CFR820;" however, I looked it up, and they do. Is this an audit per the Accredited Persons (AP) program? How far away is your company from selling products in the US market?

 

[Achal]

My first reaction was, "TUV doesn't audit against 21CFR820;" however, I looked it up, and they do. Is this an audit per the Accredited Persons (AP) program? How far away is your company from selling products in the US market?

Like I mentioned I am a beginner at my company and not involved in the decision level. I wanted to know what kind of questions they might ask? Or thing they might audit?

 

[indubioush]

What is your role at the company? Are you certain you will be involved in the audit? Have you been involved in audits before? They will basically audit you against all requirements listed in 21CFR820. Depending on your timing to the US market, they will focus on different things. For example, if you are in the early stages of product development, they won't be auditing you on process validation.

Have you read 21CFR820?

 

[Ajit Basrur]

Hello Folks,

I wanted your quick insights on TUV audits. I am a beginner at a Manufacturing Company.
Could you please share your views- What TUV looks into specifically during auditing pertaining 21 CFR 820?

Any advice or experience will be really helpful.

Thank You,
Achal

Probably your organization is going in for ISO 13485 certification. This standard strongly aligns to 21 CFR Part 820 and that could be the reason. Come back if you have more information and we can help you here.

 

[monoj mon]

Hello Folks,

I wanted your quick insights on TUV audits. I am a beginner at a Manufacturing Company.
Could you please share your views- What TUV looks into specifically during auditing pertaining 21 CFR 820?

Any advice or experience will be really helpful.

Thank You,
Achal

You should receive their agenda prior to their visit. If your company manufactures multiple devices then TUV will randomly identify one (or two) device(s) and related documentation for the device(s). It is difficult to predict which documentation section they will be interested to review as (I guess) they won't follow a pattern. Nothing better than 21 CFR 820 itself can give you the hint of documentation. If you are already in compliance to each and every (applicable) subpart of 21 CFR 820, then I don't see anything to worry about. Beside the documentation review, TUV auditor may visit your factory to check for compliance. They might be interested in checking your,

1. incoming inspection process,
2. raw material separation, identification and storage condition,
3. differentiation between non-final finished devices and final-finished devices at the storage facility. This is important when you store your packaged devices before and after sterilization under the same roof. They might be interested in looking how you make it obvious to the operator if the packaged devices went through sterilization or not.
4. How you handle your nonconformity and how do you quarantine nonconformed part(s)/devices.
5. If you manufacture your devices in a cleanroom then how do you control, such as, air flow, humidity, personnel hygiene etc.

 

[yodon]

The FDA inspectors use the QSIT guide. This is (obviously) tailored to 820 and might give you a little more insight into specifics. TUV may not necessarily play by this guidebook but it still should help you understand.